282
Participants
Start Date
December 31, 2005
Primary Completion Date
February 28, 2010
Study Completion Date
February 28, 2010
Everolimus
0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.
Mycophenolic acid (MPA)/azathioprine (AZA)
In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.
Calcineurin inhibitors (CNI)
Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.
Steroids
Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.
Novartis Investigative Site, Copenhagen
Novartis Investigative Site, Lund
Novartis Investigative Site, Aarhus
Novartis Investigative Site, Oslo
Novartis Investigative Site, Gothenburg
Novartis Investigative Site, Linköping
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY